FDA warns against use of OTC benzocaine teething products

The U.S. Food and Drug Administration has taken several actions to stop the use of over-the-counter benzocaine oral health products for young children, stating that the products “pose serious safety risks, especially those with no demonstrated benefit.”

In addition to warning consumers that these products, which are intended for the temporary relief of sore gums due to teething, pose a serious risk to infants and children, the administration is requesting that the products no longer be marketed and has asked companies to stop selling the products for such use. “If companies do not comply, the FDA will initiate a regulatory action to remove these products from the market,” the FDA states in a May 23 news release. The administration has further requested that companies add warnings to all other oral health products containing benzocaine.

The FDA cites the associated risk for methemoglobinemia with use of benzocaine products, building on previous warnings it has issued. Product labels for prescription local anesthetics will also be required to include updated warnings about their risk for the condition. 

Health care professionals and consumers should report adverse reactions involving benzocaine to the FDA’s MedWatch program. More details about the FDA’s actions as well as recommendations for consumers are available in the news release.

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In a final rule issued by the Food and Drug Administration, 24 active ingredients used in nonprescription antiseptic products are “not generally recognized as safe and effective” (GRAS/GRAE) for use by health care professionals in health care settings or situations “due to insufficient data.” The ban applies to use of these ingredients in over-the-counter antiseptics and takes effect Dec. 20, 2018.